Reuse of Intermittent Urethral Catheters

Status:	Completed
Healthy:	No
Age Range:	18 - Any
Updated:	10/14/2017
Start Date:	June 20, 2014
End Date:	March 23, 2017

Is Reuse of Intermittent Urethral Catheters Safe and Preferred? A Prospective, Observational Study Evaluating Reuse of Catheters and Switch to Single-use.

The purpose of this study is to investigate and document real life safety and satisfaction of
re-use of urethral catheters for intermittent self catheterization. The study will collect
re-used catheters from included patients and compare those to a control group with regard to
bacterial contamination and mechanical properties. A four week prospective evaluation will
follow where the patients will be given catheters intended for single-use.

Inclusion Criteria:

- Provision of informed consent

- Female and/or male aged 18 years and over

- Intermittent self-catheterization as primary bladder management method, defined as a
normal catheterization frequency of at least 4 times daily

- Reuse of the same silicon, rubber (latex) or plastic (e.g. vinyl, PVC) catheter

- Accustomed intermittent catheterization user, defined as intermittent catheterization
use for at least 3 months

- Able to use catheters of size:

40 cm, CH12 or CH14; 16'', FR12 or FR14; 15 cm, CH10 or CH12; 6'', FR10 or FR12;

Exclusion Criteria:

- Antibiotic treatment within 4 weeks prior study inclusion

- Drug or alcohol abuse or other disease of addiction

- Immunocompromising diseases or medications

- Known urological/renal anatomical abnormalities with potential impact on subject´s
compliance as judged by the investigator

- Diagnosis of severe fecal incontinence that may compromise study participation as
judged by the investigator

- Involvement in the planning and conduct of the study (applies to both Wellspect
HealthCare staff and staff at the study site)

- Previous enrollment in the present study

- Simultaneous participation in another clinical study that may interfere with the
present study, as judged by the investigator

- Severe non-compliance to protocol as judged by the investigator and/or Wellspect
HealthCare

We found this trial at

sites

North Idaho Urology

Coeur d'Alene, Idaho 83814

Principal Investigator: Randil Clark, Dr

from

Coeur d'Alene, ID